EMPLOYMENT HISTORY

ImClone Systems, Incorporated Bridgewater, NJ

Manager Clinical Trials Registry 9/07- Present
* ClinicalTrials.gov Administrator - FDAAA requirements, Results and
Adverse Events Data Disclosure
* Maintain Awareness :
* ICH and WHO guidelines
* Global Registry compliance
* State of Maine Requirements
* PhRMA Awareness
* Process Development
* Roles & responsibilities defined for Clinical Trial Disclosure &
Call Center
* Defined cross functional process flows for protocol registration,
maintenance, and results disclosure.
* Standard Operating Procedures and Desk Procedures
* Developed training program
Senior Regulatory Submissions Manager 2/07 - 9/07
* Submissions Project planner of IND's
* IND, NDA, PSUR Annual Reports
* ClinicalTrials.gov - Protocol registrations, Amendment revisions
and Site Maintenance
* Submissions: Protocol and Amendments, New Investigator, Lot
Release Amendments, CMC, Cross-Reference Letters, Annual Reports,
and Clinical Study Reports
Senior Regulatory Affairs Associate 1/06 - 2/07
* ClinicalTrials.gov - Protocol registrations, Amendment revisions
and Site Maintenance
* IND, NDA, PSUR Annual Reports
* Review clinical trials study reports
Savient Pharmaceuticals East Brunswick, NJ
Senior Regulatory Affairs Associate 08/04 - 12/05

* IND, NDA, ODA, PSUR Annual Reports

* Device & Drug Establishment Registration
* Lifecycle Maintenance various drugs
* Assemble 505b2 NDA
* Review protocols, Clinical Documentation, Submissions to IND
* Regulatory Project Manager for Safety Alerts
Consultant (Kelley Scientific) 02/03 - 08/04
Johnson & Johnson Pharmaceutical Research & Development &
Ortho McNeil Pharmaceuticals Raritan, NJ
* Trial Manager (In-House)
* Assisted in Clinical Site Selection
 * Collected and Reviewed Regulatory Documentation
* Maintained compliance for Phase I study.
* Prepare and Negotiate Clinical Trial Budgets
* Review/ Write Informed Consents
* Internal GCP review
* Review regulatory documents for FDA, ICH, and SOP compliance
* Prepared site binders for clinical site start-up
THE PHOENIX Mt. Arlington, NJ
Regulatory Compliance Manager 8/00- 11/02
* Assisted in Clinical Site Selection
* Collected and Reviewed Regulatory Documentation
* Maintained compliance for Phase I, II, III and IV studies
involving Anti-infectives, devices, Gene Therapy
* Prepare and Negotiate Clinical Trial Budgets
* Review/ Write Informed Consents
* Internal GCP review, Quality Audits and SOP generation
* Review regulatory documents for FDA, ICH, and SOP compliance
* Prepared site binders for clinical site start-up Wrote training
and procedure manuals for Departmental Tasks
* Participated and Prepared Materials for Investigator's Meetings
Analyze Findings and Determine Appropriate Corrective Plans
* Supervise 3 employees (includes 1 regional)/Performance Appraisals
* Indication/Experience: Cardiovascular, Devices, Anti-infective,
Oncology, Gene Therapy
IMMUNOMEDICS, INC. Morris Plains, NJ
Regulatory Affairs Associate 6/99- 8/00
(Total years 3 years)
* Design Case Report Forms
* Review Clinical Trial Reports prior to Regulatory Agency
Submission
* Prepare Submissions for 14 active INDs in Phase I, II, III and IV
* Maintenance of Master Files and submissions to Active INDs
* Annual Reports for 14 active INDs in Phase I, II, III and IV
* Annual Post Marketing Reports
* Complaint Coordinator for Marketed Biologics
* Internal Quality Audits and SOP generation
* Developed an Access Database for Adverse Event Reporting
* Review regulatory documents for FDA, ICH, and SOP compliance
* ClinicalTrials.gov - Protocol registrations
* Prepared site binders for clinical site start-up
* Indication/Experience: Oncology - Colorectal, Pancreatic,
Lymphatic, Liver
IRIS, INC. New York, NY
Director, Validated Systems (Consultant) 2/99 - 5/99
* Directed validation of computer systems used in pharmaceutical
environments
* Wrote training manuals for Workflow systems/Database Use
* Marketing, leasing agreements, budgets and participated in system
 sales of workflow systems
IMMUNOMEDICS, INC. Morris Plains, NJ
Regulatory Affairs Specialist 8/97 - 2/99
* Design Case Report Forms
* Prepare Submissions for 14 active INDs in Phase I, II, III and IV
* Maintenance of Master Files and submissions to Active INDs
* Annual Reports for 14 active INDs in Phase I, II, III and IV
* Annual Post Marketing Reports
* Complaint Coordinator for Marketed Biologics
* Internal and Quality Audits and SOP generation
* Developed an Access Database for Adverse Event Reporting
* Review regulatory documents for FDA and SOP compliance
* Prepared site binders for clinical site start-up
IBAH, INC. Parsippany, NJ
Regulatory Document Coordinator 3/97 - 8/97
* Review regulatory documents for FDA and SOP compliance
* Prepared site binders for clinical site start-up
* Review Informed Consents
ALTEON, INC. Ramsey, NJ
Research Data Coordinator 1/95 - 2/97
* Responsible for IND assembly for drugs used in neurological,
inflammatory bowel, and dermatology indications
* Assisted in supervising outsourcing and Project Management of GLP
Toxicology Studies
* Responsible for the Management and Imaging of Clinical and
Non-clinical Records
* Supervised the Purchase, Installation and Implementation of an
Imaging System for Records Management
* Wrote Project Management SOPs for an Imaging System for Records
Management
* Responsible for conducting literature searches using Dialog and
Grateful Med
* Indication/Experience: Diabetes, Neurological, Inflammatory Bowel,
Dermatology,

JORDAN RESEARCH CENTER Montclair, NJ Associate Scientist 7/90- 8/94

* Responsible for conducting literature searches using Dialog and
Grateful Med
* Conducted, supervised and trained personnel on laboratory
procedures
* Primary responsibilities for non-clinical studies included
protocol development, sample preparation, biochemical assays,
calibration and maintenance of instrumentation
EDUCATION:
Attending:
Stevens Institute of Technology MS in Chemical Biology/ Biotechnology.
26.5 credits completed in Biochemistry, Immunology, Physiology
Genetics, Biophysical Chemistry, Cell Signal Transduction,
Bioinformatics and Experimental Cell & Molecular Biology.
BS Biology/Minor Chemistry, May 1991
Fairleigh Dickinson University,
Madison, NJ
COMPUTER KNOWLEDGE:
Microsoft Literate in: Windows: 2007, (Access, Word, Excel, Publisher,
MS Project; Adobe Acrobat, and Visio)
MEMBERSHIPS:
Drug Information Association
Regulatory Affairs Professional Society

REFERENCES AVALIBLE UPON REQUEST

Michelle L. Struck B.S.
Michelle L. Struck B.S.
18 Second Ave.
Roseland, NJ 07068
Home: 973-403-0467
Cell 973-650-9016